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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Dry powder for inhalation, b.i.d., 4 weeks

Research Site

A 4-week, phase-II, double-blind, placebo-controlled, randomised, parallel-group, multi-centre study to assess the efficacy and tolerability/safety of inhaled AZD3199 once daily compared to 9 μg formoterol bid and placebo in patients with moderate to severe COPD

Age Continuous

Gender, Male/Female

FEV1, E0−4; the average value at visit 5 from before to 4 hours after morning dose (peak
effect)

FEV1,  E24−26; the average value at visit 5 between 24 and 26 hours following the morning
dose (trough effect)

AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.

Cmax; the highest plasma concentration of AZD3199 measured

AUC0-24; area under the plasma concentration curve from zero to 24 hours after dose

Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5

FEV1 post salbutamol inhalation

Total number of reliever medication inhalations per 24h

Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from  run-in.

Total AstraZeneca COPD symptoms scores (included breathlessness, chest tightness, cough and
night-time awakenings)

Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.

Overall mean CCQ (Clinical COPD Questionnaire)

The total score is calculated using all questions including their weights and scores range from 0 (perfect health)
to 100 (worst possible state)

Total score SGRQ-C (St George’s Respiratory Questionnaire for COPD)

Overall Study

Carin Jorup, MSD

Change from baseline to  treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)

Arms	Assigned Interventions
Experimental: 1 AZD3199 low dose	Drug: AZD3199 Dry powder for inhalation, o.d., 4 weeks
Experimental: 2 AZD3199 intermediate dose	Drug: AZD3199 Dry powder for inhalation, o.d., 4 weeks
Experimental: 3 AZD3199 high dose	Drug: AZD3199 Dry powder for inhalation, o.d., 4 weeks
Active Comparator: 4 Formoterol 2x4.5 microgram bid	Drug: formoterol Dry powder for inhalation, b.i.d., 4 weeks
Placebo Comparator: 5 Placebo	Drug: Placebo Dry powder for inhalation, b.i.d., 4 weeks

Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients - GLAD

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=237&filename=CSR-D0570C00003.pdf

D0570C00003 CSR Synopsis

Clinical Study Protocol_Redacted

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator